Seeking Alpha
  • StockMatusow
    early word has it that MAPP's Migraine drug has been rejected
    3/26/12
    Reply (37)
    • bigfoot: Nothing official yet, and stock is not reacting negatively so far
      3/26/12
    • StockMatusow: thats because its been halted for nearly 2 hours now :)
      3/26/12
    • bigfoot: well, that could do it. :-) Didn't see that :sigh:
      3/26/12
    • drjbayer: Got it Wed and rode the wave of anticipation until today at lunch and took profits. Did not want to push the luck. GL to the longs
      3/26/12
    • Maria Auziliadora: you timed it right drj
      3/26/12
    • Maria Auziliadora: I have well I had AFFY and out now
      3/26/12
    • mojojojo1: do not see shorts moving in yet . will it be another ARIA ?
      3/26/12
    • Maria Auziliadora: No I just think AFFY has ran pretty good
      3/26/12
    • bigfoot: If I was a short-term trader in AFFY, I'd agree with you, Maria.
      3/26/12
    • Maria Auziliadora: I had AFFY for over a year and taking profits is not bad
      3/26/12
    • mojojojo1: I am sorry, I was not clear .I meant MAPP
      3/26/12
    • Maria Auziliadora: no problem
      3/26/12
    • npearson86: The stock is halted so no reaction can even happen.
      3/26/12
    • Rfiglia1: Thats because the stock is halted.
      3/26/12
    • bigfoot: Looks like nothing is coming out from FDA on MAPP's levadex today.
      3/26/12
    • StockMatusow: Try $PSDV tomorrow, should move a bit
      3/26/12
    • skates77: Any comment on the CRL? No safety or efficacy issues, seems to be more CMC chemistry, manufacturing and control? Any thoughts?
      3/26/12
    • StockMatusow: i read a bit of it, seems like its more about one process of manufacturing and ease of inhaler use. should be approved next time.
      3/26/12
    • bigfoot: Not entirely unexpected.
      3/26/12
    • DougRk: Scott, what do you expect tmrw for the stock? Bloodbath, or modest pullback?
      3/26/12
    • DougRk: clarifying... I know what you think, but how do you expect the market to react?
      3/26/12
    • StockMatusow: 3 to 4, maybe close only down 2
      3/26/12
    • bigfoot: You could have picked MAPP up for as low as $11 pre-market, at $15 now.
      3/27/12
    • skates77: Off 8% now call this morning was good on safety and efficacy. Over 10,000 uses in trials, issue on manufacturing&instructions
      3/27/12
    • skates77: meeting with FDA will be scheduled in the next 14 days to take place within 75 days.
      3/27/12
    • skates77: Meeting with FDA will clarify the issues and if enough information on usability has been provided or what else is needed.
      3/27/12
    • StockMatusow: $MAPP'S drug should have been approved. Minor issue, if MAPP was $BMY, done deal. I question FDA integrity sometimes
      3/27/12
    • bigfoot: Main issue is that MAPP, unlike BMY, doesn't have its own manufacturing facilities, IMHO.
      3/27/12
    • StockMatusow: well of course you are right there, no question, but the FDA needs to do a better job working with smaller companies who simply cant afford
      3/27/12
    • bigfoot: Not sure I can agree with that. The quality of a drug's manufacturing shouldn't be a bargaining chip.
      3/27/12
    • bigfoot: In this, case, ui appears MAPP *knew* there were QC issues, they just couldn't address them in time.
      3/27/12
    • StockMatusow: so approve it on a condition, conditional approval, ive seen the FDA do this before, i do agree though, safety is paramount which brings me
      3/27/12
    • StockMatusow: VVUS; on the safety note, why would the FDA advisory commitee recommend this drug for approval? i think the benefit is not worth the risk
      3/27/12
    • StockMatusow: what say u?
      3/27/12
    • bigfoot: not familiar with the VVUS situation. My wife has migranes, so I was familiar with MAPP's product.
      3/27/12
    • bigfoot: FDA seems to be moving away from conditional approvals, it seems. They've gotten burned a few times in recent years (Vioxx, for example.)
      3/27/12
    • bigfoot: So, they're getting cautious, even with the 'fast track' drugs.
      3/27/12